Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
NCT ID: NCT04754399
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2021-04-16
2023-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Cannabidiol (CBD)
Oral solution given 2x daily.
Cannabidiol (CBD)
week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
Interventions
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Cannabidiol (CBD)
week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
* Planning to take the same AI therapy for at least 15 weeks.
* New or worsening joint pain and/or myalgias since starting the AI therapy.
* Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
Exclusion Criteria
* Planned surgery during the 15-week study period.
* Clinically significant laboratory abnormalities.
* Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
* History of or currently has suicidal ideation or attempted suicide.
* History of seizure other than febrile seizures in childhood.
18 Years
FEMALE
No
Sponsors
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American Society of Clinical Oncology
OTHER
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Norah L Henry, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Countries
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References
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Fleege NMG, Miller EA, Kidwell KM, Zacharias ZR, Houtman J, Scheu K, Kemmer K, Boehnke KF, Henry NL. Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer. Cancer Med. 2025 Aug;14(15):e71117. doi: 10.1002/cam4.71117.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00182109
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2020.041
Identifier Type: -
Identifier Source: org_study_id
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